fda warning letter glp-1 october 2025 CDER Letters Jump 50% in FY — What That Means for Industry US FDA Warning Letters: Considerations

Some may, especially if insulin resistance is present, but treatment depends on individual needs

The oral semaglutide offered through MadeMed is a compounded sublingual formulation - it is not the same product, does not use the same proprietary absorption technology, and has not been independently evaluated by the FDA for bioavailability, dosing equivalence, or absorption characteristics relative to the FDA-approved version

Whatever the outcome, any precedent or enforcement in this space may have far-reaching consequences for companies marketing similar Ozempic dupes.

If you fall into any of those categories and experience symptoms, seek medical care